Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
|ClinicalTrials.gov Identifier: NCT00690924|
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : October 11, 2017
Last Update Posted : June 4, 2018
RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the lungs.
PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in preventing lung cancer in current smokers and former smokers at high risk of lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Precancerous Condition Tobacco Use Disorder||Drug: calcitriol Other: laboratory biomarker analysis Other: pharmacological study||Not Applicable|
- To establish the safety of calcitriol in patients at high risk of lung cancer.
- To determine the dose-limiting toxicities of calcitriol in these patients.
OUTLINE: Patients receive oral calcitriol on day 1. Courses repeat every 2 weeks for 3 months in absence of unacceptable toxicity.
Patients undergo blood collection periodically for pharmacokinetic and molecular analysis.
After completion of study therapy, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer|
|Actual Study Start Date :||July 17, 2008|
|Actual Primary Completion Date :||March 7, 2017|
|Actual Study Completion Date :||March 7, 2018|
Other: laboratory biomarker analysis
Other: pharmacological study
- Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks [ Time Frame: 3 months ]
Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.
CTEP Version 4 of the CTCAE is identified and located at:
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690924
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Mary Reid, PhD||Roswell Park Cancer Institute|